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QA Specialist II Job

Eingestellt von Yoh

Gesuchte Skills: Sap, Client

Projektbeschreibung

QA SPECIALIST II needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Knowledge of SAP and Trackwise.
- Knowledge of cGMPs

WHAT YOU'LL BE DOING:

- Perform final review of manufacturing batch records for manufactured cell banks and clinical large molecule drug substance, drug product and final drug product.
- Compile Batch History Records for Product Manager review.
- Scan documents into our GMP document management system.
- Review and Interact with interdepartmental contacts on discrepancy assessment, resolution, and quality approval.
- Provide Quality oversight to internal customers in the Manufacturing organization.
- Collaborate with departments to ensure that all review activities are executed efficiently and effectively.
- Make independent decisions around complex issues in alignment with company's policies.
- Identify and implement process improvements, as necessary.

WHAT YOU NEED TO BRING TO THE TABLE:

- Knowledge of cGMPs or equivalent regulations strongly preferred
- Ability to independently evaluate situations and propose potential solutions
- Ability to interpret Quality standards for implementation
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving and work hours to meet business objectives
- Knowledge of SAP and Trackwise applications and project management skills are highly desirable.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- BS/BA degree in the life sciences plus five to seven (5-7) years experience.
- A minimum of at least five (5) years experience in Quality Assurance, Quality Control, Manufacturing, or equivalent experience.
- Thorough knowledge of cGMPs (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.

RECRUITER:Mary Nguyen

Yoh, a DayMONJOB

TAX TERM: CON_W2 J2WPACNW

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, SAP Entwicklung

  • Skills:

    sap, client

Yoh